In a special permit, the maximum allowed amount is the amount required for one year of treatment. In an application for a patient-specific special permit, this should be also considered in the prescription. The application must correspond to the prescription.
Before submitting the application to Fimea, if the medicine is prescribed for the duration of treatment, you must calculate the total quantity based on the dosage instructions indicated in the prescription and check that the quantity corresponds to the quantity indicated in the application.
In principle, the quantity is indicated considering the package size (number of packages x package size) to ensure that the pharmacy and the customer can clearly see how much of the product can be dispensed for one year of treatment.
For example, do not apply for a total of 365 tablets, if the product is only sold in packages of 100 tablets. The dose for one year corresponds to the appropriate quantity of an authorised product supplied based on a prescription. If the package size is not fully compatible with the total quantity prescribed, the pharmacy must assess the quantity to be dispensed based on pharmaceutical considerations.
The party releasing the product for consumption checks the package size and the quantity applied for before submitting the application to Fimea and appropriately marks any necessary corrections. If the total quantity and duration of treatment indicated in the prescription are ambiguous, the pharmacy must contact the prescriber for more information.